Janssen’s biologic Stelara has hit targets in a Phase III trial testing its ability to maintain clinical remission in patients with Crohn’s disease.
News
EU lifts neuropsychiatric warning for Pfizer’s Champix
European regulators have removed the black triangle warning from the label of Pfizer’s smoking cessation drug Champix, on the back of data from a post-marketing surveillance study backing its neuropsychiatric safety.
Janssen’s Darzalex gets conditional nod for multiple myeloma
Janssen’s Darzalex has received a condition approval in Europe for the treatment of multiple myeloma, offering patients with the disease access to a novel active immunotherapy.
Sandoz’ MabThera biosimilar to get EU review
European regulators have agreed to review Sandoz’ biosimilar to Roche’s oncology/immunology blockbuster rituximab.
Experts call on NHS England to commission lomitapide
Leading experts on homozygous familial hypercholesterolaemia have come together to pile pressure on NHS England to finally commission lomitapide after years of delay.
Red alert as NHS books record £2.45 billion deficit
A record 65 percent of NHS trusts ended the year 2015/16 in the red racking up the biggest overspend in its history of some £2.45 billion.
Global guidelines back Novartis’ heart drug Entresto
Novartis’ ‘breakthrough’ therapy Entresto has received a strong endorsement in updated EU and US guidelines on the treatment of heart failure.
NICE recommends NHS use of Zykadia for lung cancer
Lung cancer patients in England and Wales could soon get ‘routine’ NHS access to Novartis’ Zykadia after the National Institute for Health and Care Excellence backed its use in final draft guidelines.
UK launch for novel Parkinson’s disease drug
A new therapy for Parkinson’s disease has been launched throughout the UK, offering patients the potential to access the first new treatment option for the condition in over a decade.
Approvals round-up: 20 May
This week’s round-up of drug approvals and HTA news includes: an SMC recommendations for AbbVie’s Humira; decentralised approval in five EU countries for Martindale’s Prenoxad injection; and an EU thumbs up for BMS’ Opdivo and Yervoy
Janssen licenses DART molecule from MacroGenics
Johnson & Johnson group Janssen has signed a deal with US biopharma MacroGenics for a license to its preclinical bispecific molecule MGD015.
NICE rejects Roche’s breast cancer drug Perjeta
Cost regulators for the National Health Service in England and Wales are rejecting the use of Roche’s Perjeta to treat certain forms of breast cancer.
Horizon picks up interferon gamma-1b rights from Boehringer
Dublin-Ireland based biopharma Horizon Pharma has bagged rights to Boehringer Ingelheim’s interferon gamma-1b in an around 30 countries primarily in Europe and the Middle East for 25 million euros.
Internis launches GI friendly alendronate formulation
Internis Pharma Binosto is now widely available across the UK, offering patients with osteoporosis the chance to access the first buffered formulation of alendronate designed to minimise gastrointestinal side effects commonly linked with traditional versions of the drug.
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